摘要
目的:挖掘和评价Janus激酶(JAK)抑制剂与血栓栓塞事件不良反应(ADR)信号,为临床安全合理使用JAK抑制剂提供参考。方法:收集FDA不良事件报告系统数据库中JAK抑制剂相关的血栓栓塞事件,提取时间为药物上市至2021年第三季度,分析和评价性别及年龄因素对JAK抑制剂相关的血栓栓塞事件的影响,利用报告比值比法(reporting odds ratio, ROR)和比例报告比值法(proportional reporting ratio, PRR)进行血栓栓塞事件信号检测。结果:4种JAK抑制剂均能检测出血栓栓塞事件,芦可替尼(ruxolitinib)、托法替尼(tofacitinib)、巴瑞替尼(baricitinib)及乌帕替尼(upadacitinib)发生血栓栓塞事件的总数分别为484,1 886,157,174;在年龄构成上,芦可替尼、托法替尼、巴瑞替尼发生血栓栓塞事件的年龄多分布于65~85岁之间,乌帕替尼多分布于18~64岁之间,在性别构成上,女性均高于男性。信号结果显示肺血栓在托法替尼、乌帕替尼中可生成一个可疑信号,肺栓塞在巴瑞替尼及乌帕替尼中可生成一个可疑信号,门静脉血栓在乌帕替尼、巴瑞替尼中可生成一个可疑信号,深静脉血栓仅在巴瑞替尼中生成一个可疑信号,脑血栓在芦可替尼、托法替尼及乌帕替尼中生成一个可疑信号。结论:基于真实世界的JAK抑制剂在血栓栓塞不良反应的研究有助于药物安全性的评价,为临床安全合理用药提供依据。
OBJECTIVE To explore and evaluate the adverse reaction(ADR) signal between JAK inhibitors and thromboembolic adverse events, and to provide references for the safe and reasonable clinical application of JAK inhibitors.METHODS Collect JAK inhibitor-related thromboembolic events in the FDA Adverse Event Reporting System database, and extract the time from the drug’s market time to the third quarter of 2021,analyze and evaluate gender and age factors for JAK inhibitor-related thromboembolic events, and use reporting odds ratio(ROR) and proportional reporting ratio(PRR) for thromboembolic adverse events signal detection.RESULTS The four JAK inhibitors can detect the ADE of hemorrhagic embolism. The total number of thromboembolic events in ruxolitinib, tofacitinib, baricitinib, and upadacitinib were 484,1 886,157,and 174,respectively. The ages of thromboembolic events of ruxolitinib, tofacitinib, and baricitinib are mostly between 65 and 85 years old, and upadacitinib are mostly between 18 and 64 years old. In terms of gender composition, women are higher than men;pulmonary thrombosis can generate a suspicious signal in tofacitinib and upadacitinib;pulmonary embolism can generate a suspicious signal in baricitinib and upadacitinib;portal vein thrombosis can generate a suspicious signal in upadacitinib and baricitinib;deep vein thrombosis can generate a suspicious signal in baricitinib only;cerebral thrombosis generates a suspicious signal in ruxolitinib, tofacitinib and upadacitinib.CONCLUSION The study of JAK inhibitors in thromboembolic adverse reactions based on the real world is helpful to the evaluation of drug safety and provide basis for clinical safe and rational drug use.
作者
刘洁
汤正波
LIU Jie;TANG Zheng-bo(Department of Neonatology,The Third Affiliated Hospital of Zunyi Medical University/The First People’s Hospital of Zunyi,Guizhou Zunyi 563000,China;Department of Thoracic Surgery,The Third Affiliated Hospital of Zunyi Medical University/The First People’s Hospital of Zunyi,Guizhou Zunyi 563000,China)
出处
《中国医院药学杂志》
CAS
北大核心
2022年第10期1046-1050,共5页
Chinese Journal of Hospital Pharmacy
